Equipment Project Engineer

Summary:
A global biologics company in Waterford requires a Project Engineer to deliver a device assembly line at the facility. Delivery of this significant investment project portfolio will be within the biopharmaceutical operations for monoclonal antibodies (mAbs) medical device within the device assembly facility. The successful candidate will schedule, plan, forecast, resource and manage all activities to ensure the project schedule, cost, quality and scope adherence are maintained from conception to completion. The role will involve travel to the vendors facility to expedite the equipment and perform factory acceptance testing in conjunction with the assigned technical teams.

Responsibilities:

• Deliver operational device assembly equipment from our vendor of choice for monoclonal antibodies (mAbs) & packaging operations.
• Perform procurement, acceptance of equipment & associated infrastructure on behalf of the company and report regularly on project status throughout the project lifecycle.
• Ensure compliance environmental, health and safety codes practices, approved project KPIs, performance standards and specifications are maintained.
• Liaise with external and internal customers, suppliers, and vendors to define and deliver right first-time project deployment. Travel as required to expedite vendor delivery and perform factory acceptance testing.
• Chair and Interaction with assigned project teams to interpret their requirements and ensure approval to align project scope as requested.
• Assign responsibilities, mentor project team and maintain accurate project planning documentation as defined by the company stage gate model for project delivery.
• Communicate effectively with weekly reports to management and senior stakeholders.
• Support to other project participants to overcome obstacles when they present themselves.
• Review engineering deliverables, initiate site change controls and associate documentation required by the project life cycle.
• Responsible for delivering performance metrics for budget, schedule, scope and quality adherence.

Qualifications & Experience:

• Degree in Mechanical, Chemical, Industrial or equivalent Engineering discipline.
• 5+ years’ experience in a project management role.
• Detailed knowledge of cGMP pharmaceutical environment.
• Masters an advantage.